22 CFR 225.111 - Criteria for IRB approval of research.

(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by § 225.117.

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

Interim final rule; delay of effective and compliance dates; request for comments.

This interim final rule is effective on July 19, 2018. This interim final rule delays until July 19, 2018, the effective date and general compliance date of the final rule published in the Federal Register (82 FR 7149, Jan. 19 2017) and of the final rule published by the Consumer Product Safety Commission in the Federal Register (82 FR 43459, Sept. 18, 2017). To be assured consideration, comments must be received at one of the addresses provided below, no later than 11:59 p.m. Eastern Standard Time on March 19, 2018.

6 CFR Part 46

Summary

In a final rule published on January 19, 2017, federal departments and agencies listed in this document made revisions to the Federal Policy for the Protection of Human Subjects. The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The revised policy, reflected in both final rules, is described here as the “2018 Requirements.” The 2018 Requirements are scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). This interim final rule delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements. The limited implementation delay accomplished by this interim final rule both provides additional time to regulated entities for the preparations necessary to implement the 2018 Requirements, and additional time for the departments and agencies listed in this document to seek input from interested stakeholders through a notice and comment rulemaking process that allows for public engagement on the proposal for a further implementation delay.

DEPARTMENT OF TRANSPORTATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, ENVIRONMENTAL PROTECTION AGENCY, DEPARTMENT OF DEFENSE, NATIONAL AERONAUTICS AND SPACE ADMINISTRATION, DEPARTMENT OF COMMERCE, DEPARTMENT OF AGRICULTURE, DEPARTMENT OF ENERGY, DEPARTMENT OF HOMELAND SECURITY, SOCIAL SECURITY ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, DEPARTMENT OF EDUCATION, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT, AGENCY FOR INTERNATIONAL DEVELOPMENT, NATIONAL SCIENCE FOUNDATION

Final rule.

This rule is effective on January 19, 2018. The compliance date for this rule, except for § __.114(b) (cooperative research), is January 19, 2018. The compliance date for § __.114(b) (cooperative research) is January 20, 2020.

6 CFR Part 46

Summary

The departments and agencies listed in this document announce revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.

DEPARTMENT OF TRANSPORTATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, ENVIRONMENTAL PROTECTION AGENCY, DEPARTMENT OF DEFENSE, NATIONAL AERONAUTICS AND SPACE ADMINISTRATION, DEPARTMENT OF COMMERCE, DEPARTMENT OF AGRICULTURE, DEPARTMENT OF ENERGY, DEPARTMENT OF HOMELAND SECURITY, SOCIAL SECURITY ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, DEPARTMENT OF EDUCATION, DEPARTMENT OF JUSTICE, AGENCY FOR INTERNATIONAL DEVELOPMENT, NATIONAL SCIENCE FOUNDATION

Notice of proposed rulemaking.

The comment period for the NPRM published on September 8, 2015 (80 FR 53933), is extended by 30 days and thus will end on January 6, 2016.

6 CFR Part 46

Summary

The Department of Health and Human Services and the other Federal Departments and Agencies listed in this document are extending the comment period on the Federal Policy for the Protection of Human Subjects notice of proposed rulemaking. The NPRM requests comment on proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The NPRM was published in the Federal Register on September 8, 2015.

DEPARTMENT OF TRANSPORTATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, ENVIRONMENTAL PROTECTION AGENCY, DEPARTMENT OF DEFENSE, NATIONAL AERONAUTICS AND SPACE ADMINISTRATION, DEPARTMENT OF COMMERCE, DEPARTMENT OF AGRICULTURE, DEPARTMENT OF ENERGY, DEPARTMENT OF HOMELAND SECURITY, SOCIAL SECURITY ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, DEPARTMENT OF EDUCATION, DEPARTMENT OF JUSTICE, AGENCY FOR INTERNATIONAL DEVELOPMENT, NATIONAL SCIENCE FOUNDATION

Notice of proposed rulemaking.

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 7, 2015.

6 CFR Part 46

Summary

The departments and agencies listed in this document propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. This NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. This proposed rule is an effort to modernize, simplify, and enhance the current system of oversight. The participating departments and agencies propose these revisions to the human subjects regulations because they believe these changes would strengthen protections for research subjects while facilitating important research.